Clinical trial of galeterone for the treatment of castrate resistant prostate cancer

Recruitment & Eligibility

Status: ot Recruiting

Sex: Male

Target Recruitment: 24

Inclusion Criteria

1. Signed informed consent form (ICF) providing agreement to adhere to the dosing schedule, report for all trial visits and authorization, use and release of health and research trial information
2. Male age ? 18 years
3. Histologically or cytologically confirmed adenocarcinoma of the prostate (excluding neuroendocrine differentiation or small cell histology)
4. Ongoing androgen blockade (therapy with gonadotropin-releasing hormone (GnRH) analogues, or orchiectomy) demonstrated by serum testosterone concentration of less than 50 ng/dL
5. Demonstration of progression while on androgen blockade (based upon PCWG2 guidelines).
? Patients must have PSA levels that have risen on at least two successive occasions, at least 1 week apart, with the most recent PSA level ?2 ng/mL with or without the following:
a. Nodal spread with no evidence of bone or visceral disease
b. Bone disease with or without nodal disease and no evidence of visceral spread
c. Visceral metastases with or without nodal or bone disease
6. Eastern Cooperative Oncology Group (ECOG) Performance Status ?2
7. Life expectancy of > 12 weeks
8. Able to swallow multiple tablets whole without crunching or breaking
9. Must have tumor deposits accessible for biopsy
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 14

Exclusion Criteria

1. Participation in another clinical trial involving experimental therapy < 4 weeks prior to enrollment.

2. The following medications :
a. Prior treatment with CYP17 inhibitors or AR antagonists (e.g. abiraterone, TAK-700, ARN-509, ketoconazole*, enzalutamide, or galeterone)
* In some cases of prior ketoconazole treatment, patients may be allowed to participate based upon discussion of the individual details between the PI and the Tokai Medical Representative.
b. Prior treatment of CRPC with chemotherapy agents (including but not limited to taxanes, anthracyclines, mitoxantrone, platinators, etc.)
c. Treatment with non-steroidal oral antiandrogens (e.g. flutamide, bicalutamide or nilutamide), 5-alpha reductase inhibitors, (e.g. dutasteride, finasteride) within 4 weeks of enrollment
Note: Patients must show a continued rise in PSA (two consecutive measures at least 2 weeks apart) after the cessation of these therapies
d. Use of herbal products that may decrease PSA levels (e.g., saw palmetto) within 4 weeks of enrollment or plans to initiate treatment with any of these herbal products during the trial
e. Prior use of any chronic systemic glucocorticoids within the last 6 months (short course use at Tokai Medical Representative discretion) or plans to initiate treatment with chronic systemic glucocorticoids during the trial
f. Prior external beam radiation therapy within 3 weeks (if single fraction of radiotherapy within 2 weeks)
g. Prior treatment with radium 223-dichloride (Xofigo®) or any other therapeutic radionuclide
h. Treatment with anti arrhythmia therapy for ventricular arrhythmia ? 4 weeks prior to enrollment
i. Treatment with Coumadin® (warfarin sodium) or other anti-coagulant therapy (except aspirin) ? 4 weeks prior to enrollment
j. Ongoing treatment or plans to initiate treatment with spironolactone

3. The following laboratory findings:
a. Testosterone >50 ng/dL
b. Measured or calculated creatinine clearance ?50 ml/min (CKD-EPI calculation method)
c. Bilirubin > 2.5x the ULN
d. Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 5x the ULN
e. Hemoglobin ? 9.0 g/dL
f. Absolute neutrophil count (ANC) ? 1.5 x 109/L
g. Platelets ? 100 x 109/L
h. Serum potassium (K+) < 3.5 mmol/L

4. The following medical conditions:
a. New York Heart Association Class III or IV Congestive Heart Failure
b. Myocardial infarction/unstable angina (within the 6 months prior to enrollment)
c. Atrial fibrillation
d. History of chronic or active Hepatitis B or Hepatitis C or other known chronic liver disease (Note: Positive findings on the hepatitis panel will be reviewed by the Tokai Medical Representative to determine eligibility)
e. Known human immunodeficiency virus (HIV) infection
f. Uncontrolled hypertension (defined as systolic blood pressure > 160 mmHg or diastolic blood pressure of > 100 mmHg measured on at least two occasions, two weeks apart) despite acceptable anti-hypertension therapy
g. History of adrenal insufficiency or hyperaldosteronism
h. Gastrointestinal disorders or gastric bypass surgery including lap bands that could interfere with the absorption of galeterone
i. Serious active infections requiring systemic treatment or nonmalignant medical illnesses that are uncontrolled
j. Any history of (in the past 5 years) second malignancy, other than treated non melanoma skin cancer and superficial transitional cell carcinoma of the bladder
k. Active or uncontrolled autoimmune disease
l. Active biliar

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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